On September 3, 2013, FDA Commissioner Margaret Hamburg, M.D. announced in an email to FDA staffers that Melinda Plaisier would become the agency’s new permanent Associate Commissioner for Regulatory Affairs (ACRA). Plaisier had been the acting commissioner since last October.
In recent months there have been significant changes in the Headquarters of the Food and Drug Administration’s Office of Regulatory Affairs (ORA). We have previously covered the ORA, discussing its Office of Criminal Investigations (OCI). The OCI has played a large role in several high-profile settlements involving off-label marketing or deceptive promotional practices and is currently headed by former Department of Justice veteran, John Roth. However, unlike Roth, other notable lawyers working in leadership roles at both the ORA’s Headquarters and the Office of Global Regulatory Operations and Policy (which oversees the ORA) have recently left for other parts of the agency and the private sector. It is unclear whether this represents a shift in enforcement policy priorities at the agency or is merely a temporary trend.
Replacing the Associate Commissioner for Regulatory Affairs
With several thousand employees, the ORA has responsibility for imports, inspections and investigations, compliance and enforcement, and field laboratory operations. In October 2012, the Office was reorganized, naming Melinda Plaisier the Acting Associate Commissioner for Regulatory Affairs. As reported by Regulatory Focus:
“Filling Corrigan’s shoes until a permanent replacement can be found will be Melinda Plaisier. Plaisier has previously served as the Office of Regulatory Affairs’ (ORA) US central region director.
Before ORA, Plaisier served for 13 years in the Office of the Commissioner (OC) as the associate commissioner for international programs and then the associate commissioner for legislation.”
The previous Associate Commissioner for Regulatory Affairs (ACRA), Dara Corrigan, assumed a new role:
“The US Food and Drug Administration’s (FDA) top regulatory affairs official, Dara Corrigan, is giving up her duties and assuming a position as director of FDA’s Europe Office and as senior advisor for global operations, sources tell Regulatory Focus.
Corrigan had served as the associate commissioner for regulatory affairs since September 2010, where she was in charge of more than 4,000 staff focused on ensuring regulatory compliance in import, export and manufacturing operations for products overseen by FDA.”
Unlike Plaisier, Corrigan is an attorney, having served as Acting HHS Inspector General and co-head of Arnold & Porter’s drug and medical device practice group. There was some question as to who would become the permanent ACRA, replacing Corrigan. Would it be from industry, a private law firm, or perhaps an appointment from within HHS? FDA Commissioner Margaret Hamburg answered this question, as reported by Regulatory Focus:
“But one question has remained over the course of the last year: Would FDA ultimately appoint Plaisier to the position, or would it select another candidate, perhaps one from industry?”
The New Associate Commissioner for Regulatory Affairs
“Now FDA Commissioner Margaret Hamburg has put those questions to rest, writing in a 3 September 2013 email to FDA staff that Plaisier has been made ACRA on a permanent basis.
‘As many of you know, Melinda has been steadfastly serving in this position in an acting role since October 1, 2012,’ Hamburg wrote. ‘During that time, Melinda has led the Office of Regulatory Affairs (ORA), utilizing her deep operational knowledge, her proven leadership skills, and her professional and collaborative demeanor.'”
Regulatory Focus points out Plaisier’s legislative experience and a possible connection to compound pharmacy legislation:
“Plaisier’s legislative experience, which includes experience as a congressional staffer prior to working at FDA, may well come in handy as the agency continues to press for additional regulatory authority with which to go after deficient pharmaceutical compounding practices. While legislation to do just that has seen relatively easy passage in the Senate, its passage in the House of Representatives has been markedly more contentious. A voice for regulatory enforcement with deep-seated knowledge of the legislative process, then, may be a strong asset in making sure the legislation ultimately sees passage.”
2012 Meningitis Outbreak and Congressional Investigation
The compounding legislation stems from the nation’s 2012 meningitis outbreak. This public health crisis sparked a Congressional investigation into compound pharmacies and the FDA’s enforcement actions:
“The head of the U.S. Food and Drug Administration conceded on Tuesday that the agency could have been more aggressive in its oversight of the compounding pharmacy at the center of a deadly meningitis outbreak.
Testifying at a contentious congressional hearing, FDA Commissioner Margaret Hamburg said a confusing legal landscape, combined with resistance from compounding pharmacies, had hampered her agency’s ability to act on a myriad of complaints against the New England Compounding Center and its sister company, Ameridose LLC.
‘I wish we had acted earlier,’ Hamburg told a House Energy and Commerce subcommittee looking into the outbreak, which has killed 53 people and sickened more than 700.
The hearing was the second held by the committee to determine whether the FDA could have prevented the outbreak and whether it needs greater powers to regulate pharmacies that compound drugs tailored for specific patients. In the past decade, some have come to operate more like traditional pharmaceutical manufacturers, but without the same oversight.”
Congressional activities regarding the issue are ongoing, but the November 2012 testimony by FDA Commissioner Hamburg has been described as “contentious“. After the November 2012 hearing, Congress went so far as to threaten the agency with a subpoena:
“US regulators are coming under renewed scrutiny regarding their oversight of pharmaceutical compounders, with House legislators threatening to subpoena the US Food and Drug Administration for what they allege is a failure to provide relevant documents to the Energy and Commerce Committee despite repeated requests.”
“FDA, legislators said, has released some documents, but the large majority of those were already publicly available, such as Form 483 inspection reports. Other private documents produced, they added, are ‘markedly incomplete.’
The FDA has produced three separate inspections of NECC’s facilities, documented numerous public health and safety concerns, and considered enforcement actions against the firm,’ they continued. ‘FDA has produced no communications from staff and officials at FDA headquarters, who were actually making the decisions about how to address the situation at NECC. In addition, FDA took three months to produce a one-and-a-half page timeline of its involvement with the company, a document Committee staff requested on 12 October 2012 during its first teleconference with FDA related to the outbreak of meningitis.'”
Promotion of ORA’s Deputy Associate Commissioner for Regulatory Affairs to Lead CDER Compliance
In response to the ongoing efforts to further regulate compounding pharmacies, Howard Sklamberg, the ORA’s Deputy Associate Commissioner for Regulatory Affairs (serving under Associate Commissioner Plaisier) was promoted in November of 2012 to become the director of the FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance, a job he started in January of 2013.
Sklamberg, an attorney with experience at the Department of Justice, left the ORA having served as Deputy Associate Commissioner since July 2011. Skalmberg’s acting replacement is agency veteran Steve Solomon. Prior to joining the FDA, Solomon owned and operated a private veterinary practice. At the agency, he was previously the Associate Director for Global Operations and Policy in the Office of Global Regulatory Operations and Policy, and also the Deputy Associate Commissioner for Compliance Policy in the ORA.
Top Regulator Leaves for Private Sector
Additionally, only a few months later, Deborah Autor, the Deputy Commissioner for the FDA’s office of Global Regulatory Operations and Policy (GO) left the agency to join Mylan Pharmaceuticals. Like Sklamberg, Autor was heavily involved in the meningitis and compounding pharmacy debate. She also served as the director of CDER’s Office of Compliance after previously working as a litigator at the Department of Justice and in private practice.
As noted by Regulatory Focus:
“[ORA’s now permanent Associate Commissioner for Regulatory Affairs] Plaisier will be reporting directly to the deputy commissioner for global regulatory operations and policy (GO), a position that remains unfilled after it was recently vacated by Deborah Autor.”
Impact on Agency Priorities and Enforcement Activities
It is not uncommon for regulators to change jobs. But it is interesting to see three notable attorneys, all serving in leadership roles at the Office of Regulatory Affairs and Office of Global Regulatory Operations and Policy, moving on to new positions within a short period of time.
Looking back to August 2009, FDA Commissioner Hamburg started her tenure by outlining a “tough new enforcement agenda” in response to complaints that the agency’s enforcement actions were “bogged down by arduous processes at the agency” resulting in unacceptable delays in actions to protect the public health. For example, Hamburg modified agency policy to streamline the process for issuing some warning letters without review by the FDA Office of Chief Counsel:
“In the Commissioner’s discussion regarding accelerating warning letter procedures, she noted that the past policy under the prior Administration had required all letters to be reviewed by FDA’s Office of Chief Counsel (OCC). Under the new process this will no longer be required. Commissioner Hamburg explained the former policy was too cumbersome without providing benefit. Under the new policy, therefore, only letters involving novel, complex, or sensitive issues will require OCC review.”
The Commissioner also placed a special emphasis on “the integration of internal and field work operations of the FDA. She explained that she would like to see the FDA more effectively explain enforcement actions and regulations to the public, and to engage more actively with the public to identify areas in which FDA should be more vigilant.”
Given the Commissioner’s 2009 interest in increased enforcement and inspection activities, it was not surprising to see elite government and private sector attorneys being placed into leadership roles at the Office of Regulatory Affairs and Office of Global Regulatory Operations and Policy. However, these lawyers have moved on to new opportunities. While some of their previous positions currently remain vacant, other spots have been filled by temporary or permanent staff hires. In doing so, there is some evidence FDA is placing an emphasis on promoting regulators who possess different professional backgrounds to leadership posts. Time will tell if this trend continues and if their promotions alter any form of the agency’s enforcement strategies. This is especially important as the FDA continues to request additional authority to regulate compounding pharmacies and starts to implement new food and drug laws.